Trifluoperazine Hydrochloride

ANDA 85787, held by Chartwell Rx. Trifluoperazine Hydrochloride.

As of Nov 15, 2026, ANDA 85787 (Trifluoperazine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Apr 15, 1982, with 21 approved supplements and 0 published complete response letters.

First approved: Apr 15, 1982
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Apr 15, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trifluoperazine HydrochlorideEQ 10MG BASE/ML · concentrate;oral	Trifluoperazine Hydrochloride	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 33Labeling · Standard review	Approved	None posted
Jan 14, 2025	Supplement 32Labeling · Standard review	Approved	None posted
Mar 19, 2015	Supplement 31Labeling	Approved	None posted
Jan 24, 1994	Supplement 30Manufacturing	Approved	None posted
Jul 29, 1992	Supplement 29Labeling	Approved	None posted
Oct 11, 1989	Supplement 34Labeling	Approved	None posted
Oct 10, 1989	Supplement 25Labeling	Approved	None posted
Sep 15, 1989	Supplement 26Labeling	Approved	None posted
Mar 16, 1988	Supplement 22Manufacturing	Approved	None posted
Mar 16, 1988	Supplement 21Manufacturing	Approved	None posted
Jul 30, 1986	Supplement 17Manufacturing	Approved	None posted
Aug 3, 1984	Supplement 14Manufacturing	Approved	None posted
May 2, 1984	Supplement 12Manufacturing	Approved	None posted
Apr 13, 1984	Supplement 11Manufacturing	Approved	None posted
Feb 1, 1984	Supplement 9Manufacturing	Approved	None posted
May 19, 1983	Supplement 8Manufacturing	Approved	None posted
Dec 9, 1982	Supplement 7Manufacturing	Approved	None posted
Dec 9, 1982	Supplement 6Manufacturing	Approved	None posted
Dec 9, 1982	Supplement 5Manufacturing	Approved	None posted
Oct 28, 1982	Supplement 3Manufacturing	Approved	None posted
Sep 22, 1982	Supplement 4Manufacturing	Approved	None posted
Apr 15, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 85787
Drugs@FDA: Overview at FDA
Company: Chartwell RX

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters